Clinical trial · Interventional
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study details changed, new Trial Registration process begun for modified protocol
Summary
Brief summary (as posted)
The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Surgical Site Infection | — | UNRESOLVED | — |
| Wound Dehiscence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative Pressure Wound Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative Pressure Wound Therapy
- description
- This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, AND the negative pressure wound therapy. The Prevena™ Incision Management System will be placed at the abdominal flap donor site after incision is closed. The Prevena™ will remain for up to 5 days, or until patient is discharged from the hospital.
- interventionNames
- Device: Negative Pressure Wound Therapy
- type
- ACTIVE_COMPARATOR
- label
- Standard Dressing
- description
- This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, and standard dressing which will be composed of gauze, secured with paper tape.
- interventionNames
- Device: Negative Pressure Wound Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy * Patients going either unilateral or bilateral reconstruction Exclusion Criteria: * Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. - * Patients who have contraindications to the ciNPT * Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study. * Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study.
References
Publications (0)
Data not yet available